BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM

    MDR report key: 2160392 · Received July 13, 2011

    Report

    Report Number
    6000034-2011-00475
    Event Type
    Malfunction
    Date Received
    July 13, 2011
    Date of Event
    June 27, 2011
    Report Date
    February 7, 2012
    Manufacturer
    COCHLEAR LTD.
    Product Code
    MCM
    PMA / PMN Number
    970051
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PER THE PATIENT'S SURGEON, THE DEVICE WAS EXPLANTED ON (B)(6) 2011. DURING THE SAME SURGERY THE PATIENT WAS REIMPLANTED WITH A NEW DEVICE. THIS REPORT IS FILED (B)(4) 2012.

    Additional Manufacturer Narrative · 1

    (B)(4). IMPLANTED DEVICE REMAINS.

    Description of Event or Problem · 1

    PER THE CLINIC, THE PATIENT SUSTAINED A BLOW TO THE HEAD RESULTING IN A LOSS OF CONNECTION TO THE INTERNAL DEVICE. IT IS UNKNOWN WHETHER THERE ARE PLANS TO EXPLANT THE DEVICE AND TO REIMPLANT THE PATIENT WITH ANOTHER DEVICE AT THE TIME OF THIS REPORT (B)(6), 2011.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 NUCLEUS 24 CHANNEL COCHLEAR IMPLANT SYSTEM MCM MCM COCHLEAR LTD. CI24R (CA) N/A

    Patients

    Seq Age Sex Outcome Treatment
    1 10 YR Required Intervention